Country: United States
Language: English
Source: NLM (National Library of Medicine)
fentanyl (UNII: UF599785JZ) (fentanyl - UNII:UF599785JZ)
Janssen Pharmaceuticals, Inc.
fentanyl
fentanyl 12.5 ug in 1 h
TRANSDERMAL
PRESCRIPTION DRUG
DURAGESIC is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)] , reserve DURAGESIC for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide suffi
DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems. Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Store DURAGESIC securely and dispose of properly [see Patient Counseling Information (17)] .
New Drug Application
Janssen Pharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 10/2019 Medication Guide DURAGESIC ® (Dur-ah-GEE-zik ) (fentanyl) Transdermal System, CII DURAGESIC ® is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. • Not for use to treat pain that is not around-the-clock. Important information about DURAGESIC ® : • Get emergency help right away if you use too much DURAGESIC ® (overdose) . When you first start taking DURAGESIC ® , when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur. • Taking DURAGESIC ® with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) may cause severe drowsiness, decreased awareness, breathing difficulties, with slow or shallow breathing, coma, and death. • Never give anyone else your DURAGESIC ® . They could die from taking it. Selling or giving away DURAGESIC ® is against the law. • Store DURAGESIC ® , securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. • If the patch accidentally sticks to a family member while in close contact, take the patch off, wash the area with water, and get emergency help right away because an accidental exposure to DURAGESIC ® can lead to death or other Read the complete document
DURAGESIC- FENTANYL PATCH JANSSEN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DURAGESIC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DURAGESIC. DURAGESIC (FENTANYL TRANSDERMAL SYSTEM) FOR TRANSDERMAL ADMINISTRATION, CII INITIAL U.S. APPROVAL: 1968 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; AND RISKS FROM CONCOMITANT USE OF BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DURAGESIC EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT'S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY FOR THESE BEHAVIORS OR CONDITIONS. (5.1) TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2) SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR. MONITOR CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.3) ACCIDENTAL EXPOSURE TO DURAGESIC, ESPECIALLY IN CHILDREN, CAN RESULT IN FATAL OVERDOSE OF FENTANYL. (5.4 ) PROLONGED USE OF DURAGESIC DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.5) CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4 INDUCERS) CAN RESULT IN A FATAL OVERDOSE OF FENTANYL. (5.6) EXPOSURE OF THE DURAGESIC APPLICATION SITE AND SURROUNDING AREA TO DIRECT EXTER Read the complete document